RelayPro Thoracic Stent-Graft System 28-M4-36-190-32URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150256), received between Nov 25, 2025 and Nov 25, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P200045); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  "DISSECTION: ON AUGUST 12, THE PATIENT WITH A DISSECTING AORTIC ANEURYSM UNDERWENT TEVAR AND HAD THE RELAY PRO STENT-GRAFT (BS, 36 MM) IMPLANTED IN THE PROXIMAL SEALING PORTION (VESSEL DIAMETERS: 30 MM - 27 MM - 33 MM). ON THURSDAY EVENING, OCTOBER 30, RETROGRADE TYPE A AORTIC DISSECTION (RTAD) OCCURRED AT THE BARE-STENT ON THE LESSER CURVATURE SIDE OF THE RELAY PRO STENT-GRAFT, REQUIRING RE-INTERVENTION. ON FRIDAY, OCTOBER 31, TOTAL ARCH REPLACEMENT (TAR) WAS PERFORMED. A THORAFLEX HYBRID WITH A STENT DIAMETER OF 30 MM WAS IMPLANTED, AND THE ENTRY WAS RESECTED. THE SURGERY WAS SUCCESSFULLY COMPLETED, AND INFORMATION ON POSTOPERATIVE PROGRESS WILL BE OBTAINED LATER. PHYSICIAN'S COMMENTS ON CAUSALITY: THIS EVENT MAY HAVE BEEN DUE TO THE LARGE DIAMETER OF THE STENT-GRAFT AND THE SELECTION OF THE RELAY PRO BARE-STENT TYPE. PHYSICIAN'S COMMENT: THE LARGE DIAMETER OF THE STENT-GRAFT AND THE PLAN TO USE THE RELAY PRO BARE-STENT TYPE FOR THE DISSECTING AORTIC ANEURYSM MAY NOT HAVE BEEN UNDESIRABLE. OPERATION TYPE: TEVAR BLOOD LOSS: UNKNOWN. IMAGE WILL BE ABLE TO BE OBTAINED. PRE-CASE PLAN WILL BE ABLE TO BE OBTAINED. ADDITIONAL INFORMATION WILL BE ABLE TO BE OBTAINED. (TC#(B)(4))". PATIEN

  Patient problems: Vascular Dissection

  MAUDE report 23645269 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P200045. One submission often covers many models, so check the product and lot details in each record.

• Z-2160-2026 · Apr 22, 2026 · Open, Classified
  RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-
• Z-1383-2024 · Feb 22, 2024 · Completed
  RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 2